1. Field of the Disclosure
The present disclosure generally relates to the computer storage and management of clinical trials. In particular, the present disclosure relates to upgrading or altering a particular protocol of a particular clinical trial.
2. Description of the Related Art
Before a new medical treatment (e.g., pharmaceuticals) or device (e.g., surgical instruments or implants) may be dispensed to the public, the United States Food and Drug Administration (FDA) requires that the manufacturers of the pharmaceuticals, devices, instruments, or implants conduct extensive clinical trial research in order to demonstrate the clinical effectiveness, safety, and medical advantage of their products. Extensive and often complex clinical trial protocols are developed that define, for example, targeted demographics, proposed medications, patient regimens, forms for collection, types of statistically relevant data, the timing or order of events within the study, often even the layout of the reporting data, or other suitable data. These protocols are often sufficiently complex that the protocols themselves receive FDA approval.
Once a protocol is developed and approved, companies design electronic data capture and data management solutions to manage the data gathered over the course of the clinical trial. This typically includes configuring a database to store the patient data as well as study metadata. The study metadata generally defines events (and scheduling thereof), Case Report Forms (CRFs), data points and their grouping, code lists, business rules, and derivatives (calculated fields). In general, such data capture and data management solutions capture data from geographically disparate clinicians or study participants, defining many points of data entry, potentially across many software and hardware platforms.
During the course of a clinical trial, one or more protocol amendments may occur, such as when new information becomes available or by request of a sponsor or regulatory agency (e.g. the FDA). Protocol amendments occur for a variety of reasons. Sometimes additional or more specific information is desired; other times a clinical trial is started as early as possible and details are fleshed out along the way. Still other times, protocol amendments merely involve clarification of forms that are used. A protocol amendment often requires a different version of a study, and each participating site (typically each physician's office or hospital) generally needs to receive Institutional Review Board (IRB) approval prior to the deployment of a new version of the study metadata. These approvals take varying amounts of time and it would generally be inefficient, if not impractical, to wait for all approvals before updating the trial protocol. Even when possible to wait for each participating location to approve a protocol change, valuable data may be lost by holding back the early adopters. As such, allowing different sites to utilize different versions of the trial protocol is advantageous.
Most systems that attempt versioning create new databases and import the data from a previous database to the new one. One drawback of this sort of versioning is the potential for data corruption or loss when moving the patient records from one protocol to another. Another drawback is that this sort of versioning may also cause a need for revalidation of the data or the system by the FDA. It is therefore desirable to provide a system and method of protocol versioning which reduces or eliminates the need to move data.